Download Our Brief: Behind the Breakthrough

Every trial will have surprises. The key is how your team pivots to resolve issues and seize opportunity – all the more intense when worldwide regulatory agencies are providing daily guidance. See what happens in a Breakthrough Therapy trial, and when the stakes are sky high.

The proof lies in the groundbreaking approvals we’ve supported, including those with the worldwide regulatory agencies new Breakthrough Therapy designation.

Breakthrough vs. Regular Approval Pathways

Whether you pursue the highly prized Breakthrough Therapy designation or other pathways, medical imaging serves as a surrogate endpoint, revealing the effect of a drug much earlier than traditional endpoints.

Download Our Brief: Behind the Breakthrough

Every trial will have surprises. The key is how your team pivots to resolve issues and seize opportunity – all the more intense when worldwide regulatory agencies are providing daily guidance. See what happens in a Breakthrough Therapy trial, and when the stakes are sky high.